MityOne

GUDID 20888937003127

Pump with M-Style Mushroom Cup

Coopersurgical, Inc.

Foetal vacuum extraction system cup, single-use

• Primary Device ID: 20888937003127
• NIH Device Record Key: 6a97f6a9-6f1e-4a6f-8c59-da76769b2924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MityOne
• Version Model Number: 10067
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003123 [Primary]
GS1	20888937003127 [Package]; Contains: 00888937003123; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890307

FDA Product Code

• HDB: Extractor, Vacuum, Fetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-08-10

On-Brand Devices [MityOne]

• 20888937003134: Pump with MitySoft Bell Cup
• 20888937003127: Pump with M-Style Mushroom Cup